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Pharmacogenetics for Pain Management in Joint Replacement Patients (PGx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772535
Recruitment Status : Enrolling by invitation
First Posted : December 11, 2018
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Anderson Orthopaedic Research Institute

Tracking Information
First Submitted Date  ICMJE December 10, 2018
First Posted Date  ICMJE December 11, 2018
Last Update Posted Date August 1, 2019
Actual Study Start Date  ICMJE December 3, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
Genetic variants [ Time Frame: 10 days postoperative ]
Percent of subject with genetic variants affecting pain medication
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2019)
pain levels [ Time Frame: 10 days postoperatively ]
0-10 subjective pain scale
Original Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
pain levels [ Time Frame: 10 days postoperatively ]
1-10 subjective pain scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacogenetics for Pain Management in Joint Replacement Patients
Official Title  ICMJE Using Pharmacogenetics to Structure Individual Pain Management Protocols for Joint Replacement Patients
Brief Summary The purpose of this study is to determine the ability to use pharmacogenetic testing in a joint replacement practice to prescribe the most effective pain medicine for a specific patient.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Condition  ICMJE Arthroplasty Complications
Intervention  ICMJE Diagnostic Test: Pharmacogenomics Testing
The doctor will use genetic test results to prescribe medications that are a most effective for subject.
Study Arms  ICMJE
  • No Intervention: Control Group
    Subjects in this arm will receive the standard postoperative pain prescription protocol.
  • Active Comparator: Pharmacogenomics Guided Group
    Subjects in this group will receive postoperative pain prescriptions based on the results of pharmacogenomic testing.
    Intervention: Diagnostic Test: Pharmacogenomics Testing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Actual Enrollment  ICMJE
 (submitted: December 10, 2018)
50
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Primary total hip or total knee arthroplasty cases

Exclusion Criteria:

  • History of narcotic dependence
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03772535
Other Study ID Numbers  ICMJE AORI 2018-0100
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anderson Orthopaedic Research Institute
Study Sponsor  ICMJE Anderson Orthopaedic Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William Hamilton, MD Anderson Orthopaedic Research Institute
PRS Account Anderson Orthopaedic Research Institute
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP